Lupus ErythematosusLES-HYDROXYNCT06161363
Description of Compliance With Hydroxychloroquine Treatment in Patients With Systemic Lupus Erythematosus
An observational study of Lupus Erythematosus, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The project focuses on non-compliance in patients with systemic lupus erythematosus taking Plaquenil. More than half of patients with chronic illness are not or only poorly compliant with their treatment and lupus is one of them. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lupus Erythematosus
- What is being tested?
- The Morisky Medication Adherence Scale
- How many people
- 102 participants
- Where
- 1 siteFrance
- Study dates
- 27 Nov 2023to 16 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with systemic lupus erythematosus
Who may be able to join
- Age >18 years
- Patient with systemic lupus erythematosus
- Treatment with PLAQUENIL for > 6 months with dosage of hydroxychloroquinemia planned during the consultation.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Description of Compliance With Hydroxychloroquine Treatment in Patients With Systemic Lupus Erythematosus in a Hospital Internal Medicine Consultation
The project focuses on non-compliance in patients with systemic lupus erythematosus taking Plaquenil. More than half of patients with chronic illness are not or only poorly compliant with their treatment and lupus is one of them.
The investigators want to use an already validated existing questionnaire in English, the Morisky Medication Adherence Scale 8 (MMAS 8). These results will make it possible, after a multivariate study with reference to the gold standard which is hydroxychloroquinemia, to see which exact questions in the questionnaire can be used in general medicine practices in order to detect less or non-compliant patients as early as possible.
- Conditions
- Lupus Erythematosus
- Being tested
- The Morisky Medication Adherence Scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Morisky Medication Adherence ScaleOther
The Morisky Medication Adherence Scale will be completed bu the patients
| Study group | Role | What they receive |
|---|---|---|
| The Morisky Medication Adherence Scale (MMAS-8) | The Morisky Medication Adherence Scale completed by the patients Receives: Other: The Morisky Medication Adherence Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-compliance with hydroxychloroquine treatment
to describe the non-compliance with hydroxychloroquine treatment with the Morisky Medication Adherence Scale
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start27 Nov 2023
- Primary completion16 Nov 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161363
- Sponsor's protocol ID
- RC31/23/0473
- Acronym
- LES-HYDROXY
- Status last verified
- Dec 2025
- First submitted
- 29 Nov 2023
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of Compliance With Hydroxychloroquine Treatment in Patients With Systemic Lupus Erythematosus in a Hospital Internal Medicine Consultation
- ClinicalTrials.gov ID
- NCT06161363
- Acronym / sponsor ID
- LES-HYDROXY / RC31/23/0473
- Conditions
- Lupus Erythematosus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 16 Nov 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project focuses on non-compliance in patients with systemic lupus erythematosus taking Plaquenil. More than half of patients with chronic illness are not or only poorly compliant with their treatment and lupus is one of them.
The investigators want to use an already validated existing questionnaire in English, the Morisky Medication Adherence Scale 8 (MMAS 8). These results will make it possible, after a multivariate study with reference to the gold standard which is hydroxychloroquinemia, to see which exact questions in the questionnaire can be used in general medicine practices in order to detect less or non-compliant patients as early as possible.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Morisky Medication Adherence Scale (MMAS-8) | – | Other: The Morisky Medication Adherence ScaleThe Morisky Medication Adherence Scale completed by the patients |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with systemic lupus erythematosus
Key inclusion criteria (3 listed)
- Age >18 years
- Patient with systemic lupus erythematosus
- Treatment with PLAQUENIL for > 6 months with dosage of hydroxychloroquinemia planned during the consultation.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Morisky Medication Adherence ScaleThe Morisky Medication Adherence Scale will be completed bu the patients | Other | The Morisky Medication Adherence Scale (MMAS-8) |
Primary outcome
Non-compliance with hydroxychloroquine treatment
Time frame: Day 0
to describe the non-compliance with hydroxychloroquine treatment with the Morisky Medication Adherence Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Erythematosus, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-compliance with hydroxychloroquine treatment (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.